Bayer Submits Eylea (Aflibercept) for Regulatory Approval in EU and Japan for Retinopathy of Prematurity in Preterm Infants

News on November 10, 2021 /BioValleyBIOON/ --Bayer(Bayer) recently announced that it has submitted ophthalmic drugs in the EU and Japan.Eylea (Eyelea®, generic name: aflibercept, intravitreal injection solution)A New Therapeutic Indication Application:For preterm infants, treating retinopathy of prematurity (ROP) that requires treatment.. Results from the Phase 3 FIREFLEYE study showed,The success rate of Eylea treatment is numerically higher than that of laser surgery (85.5% vs 82.1%), and it is typically achieved with just a single injection per eligible eye, with a lower frequency of need for rescue treatments and reduced requirements for general anesthesia.

ROP is one of the most severe eye diseases that requires treatment and can lead to serious visual impairment and blindness secondary to retinal detachment. It is estimated that approximately 50,000 premature infants who survive the neonatal period develop vision-threatening ROP worldwide each year. Laser surgery is the standard care method for ROP, which destroys retinal tissue and may be associated with severe complications such as high myopia.

This application is based on the final results of the 6-month Phase 3 FIREFLEYE study (comparing Eylea 0.4mg vs laser surgery) presented at the 21st Congress of the European Society of Retina Specialists (EURETINA) in September 2021, as well as interim data from the ongoing long-term follow-up Phase 3b FIREFLEYE NEXT study.

In the FIREFLEYE study, Eylea demonstrated a positive benefit-risk profile in ROP patients treated across 27 countries worldwide.FIREFLEYE Study is the first randomized prospective study comparing Eylea with laser surgery in preterm infants with ROP requiring treatment.Clinical Trial. Although the FIREFLEYE study missed statistical significance in comparing the non-inferiority primary endpoint of Eylea 0.4mg versus laser surgery (treatment difference 90% CI: -8.0% to +16.2%),Eylea 0.4mg Treatment Success (85.5%)Considered to be clinically relevant. In the control group (In laser surgery, an 82.1% success rate was observed.In the study, Eylea was proven to be effective, safe, and well-tolerated.

Christian Rommel, PhD, Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of Research and Development, stated: "Our clinical development program for preterm infants with ROP will address a significant medical need in this vulnerable pediatric patient population facing severe vision impairment. The regulatory submissions in the EU and Japan mark another step in our commitment to addressing patients' needs in ophthalmology care."

Retinopathy of Prematurity (ROP) is a vascular disease of the immature retina in premature infants, characterized by incomplete vascular growth, leading to elevated levels of intraocular vascular endothelial growth factor (VEGF) and abnormal blood vessel growth. Key risk factors include low gestational age and low birth weight at birth. Mild ROP often regresses spontaneously, while severe ROP requires timely treatment.Laser surgery is the standard care method for ROP, which damages retinal tissue and may be associated with severe complications such as high myopia.Injecting the VEGF inhibitor Eylea into the eye aims at the elevated intraocular VEGF levels.

VEGF is a naturally occurring protein in the human body. Its normal function in a healthy organism is to trigger the formation of new blood vessels (angiogenesis) that support the growth of bodily tissues and organs. It is also associated with the growth of abnormal new blood vessels in the eye, which exhibit increased abnormal permeability, leading to edema.

Eylea is a novel VEGF inhibitor for intravitreal injection, a recombinant fusion protein composed of the extracellular domains of human VEGF receptors 1 and 2 fused to the Fc portion of human IgG1, formulated as an isotonic solution for intravitreal injection. Eylea functions as a soluble decoy receptor for members of the VEGF family (including VEGF-A) and placental growth factor (PIGF), with very high affinity for these factors, thereby inhibiting their binding and activation with cognate VEGF receptors. Thus, Eylea can inhibit abnormal angiogenesis and leakage.

For patients with vision impairment due to various retinal diseases, Eylea is an effective treatment option. In reducing preventable vision loss, the drug has consistently demonstrated positive outcomes, both in randomized clinical trials and real-world clinical settings.

To date, Eylea has been approved in more than 100 countries worldwide for five indications in adults, treating vision impairment caused by retinal disorders, includingDiabetesDiabetic macular edema (DME), neovascular age-related macular degeneration (nAMD), retinal vein occlusion (RVO, including BRVO and CRVO), and vision impairment caused by pathological myopic choroidal neovascularization (myopic CNV).

Eylea is globally developed by Bayer in collaboration with Regeneron for the treatment of various retinal diseases. Regeneron retains exclusive rights in the United States, while Bayer is licensed to hold the exclusive sales rights outside the U.S. Since its global launch, approximately 47 million vials of Eylea have been sold, accumulating over 6.8 million patient-years of treatment experience. (Bioon.com)

Source of the original text:Bayer Submits Aflibercept for regulatory approval in the EU and Japan for Retinopathy of Prematurity in premature babies